MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH LIGHT-GUIDE CABLE, 2.8 MM, 3 M, CF TYPE; LIGHT GUIDE AND ACCESSORIES

Model Number	WA03300A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect medical device was not returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.However, it was reported that the patient sustained burn injuries when the light-guide cable was removed from the optical tube and placed on the patient.The issue described strongly indicates a user error.Since the exact lot number of the affected device could not be determined, a manufacturing and quality control review was performed for all lot numbers (173w0001, 174w0003, 17zw0004, 197w0001 and 203w0005) of the respective light-guide cable delivered to the user facility without showing any abnormalities.Therefore, a material or quality problem can be excluded.In addition, it was reported that the affected light-guide cable is still in use at the user facility.This indicates that the device still meets its specification.The case will be closed from olympus side with no further actions.However, the reported event/incident will be recorded for trending and surveillance purposes.
Additional Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the patient's outcome and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Event or Problem Description
Olympus was informed that during an unspecified therapeutic procedure the patient sustained burn injuries when the light-guide cable was removed from the optical tube and placed on the patient.No further information was provided but the intended procedure was completed using the same set of equipment.

• Brand Name: LIGHT-GUIDE CABLE, 2.8 MM, 3 M, CF TYPE
• Common Device Name: LIGHT GUIDE AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• MDR Report Key: 11235093
• Report Number: 9610773-2021-00057
• Device Sequence Number: 14264815
• Product Code: HBI
• UDI-Device Identifier: 04042761082297
• UDI-Public: 04042761082297
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: WA03300A
• Device Catalogue Number: WA03300A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention